BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 1000 DEFIBRILLATOR

    MDR report key: 1890426 · Received October 20, 2010

    Report

    Report Number
    3015876-2010-01147
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. IT WAS OBSERVED THAT THE DEVICE WOULD POWER OFF WHEN EITHER THE ON/OFF BUTTON WAS PRESSED OR SOFT KEY 2, WHICH IN MANUAL MODE IS THE CHARGE BUTTON. THE DEVICE THEREFORE WOULD NOT BE ABLE TO CHARGE IN MANUAL MODE ALTHOUGH IT WOULD STILL FUNCTION IN AED MODE. THE CAUSE OF THE REPORTED FAILURE WAS DETERMINED TO BE A DEFECTIVE MEMBRANE SWITCH FLEX CIRCUIT. THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS DISPLAYING A LOW BATTERY MESSAGE AND THE WRENCH ICON. IT WAS ALSO INDICATED THAT THE BATTERY WAS DEAD. THERE WERE NO REPORTS OF PT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 1000 DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC. 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA